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Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

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Regulating and Approving Drugs Video Series

FDA uses science and data to ensure that approved drugs are of a high quality, safe, and effective. Learn more about the FDA’s role in reviewing, approving, and monitoring drugs in the latest videos that are now available in Spanish.

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Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

Search our databases:

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

News

DNA molecule

FDA approves first rapid-acting biosimilar insulin for diabetes treatment

Medication helps lower mealtime blood sugar spikes in adults and children
Drug Safety Communication image

FDA warns about rare anaphylactic reaction with certain MS drugs

Urgent treatment needed if common symptoms after injection worsen or continue
Spotlight on CDER Science logo

CDER experts help develop a nitrosamines acceptable intake limit approach

Approach shown to identify nitrosamines of the highest risk

Navigate the Drugs Section

Center

Upcoming Drug-related Events

Priority Areas & Initiatives

Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Shortages

Search the database, learn about root causes and potential solutions

Resources

Information for consumers, health professionals, and industry

CENTER FOR DRUG EVALUATION AND RESEARCH

Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free
(855) 543-3784
(301) 796-3400

Hours Available

CDER Division of Drug Information

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@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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